Kornimate/medical-research-clean huggingface dataset:
follow-up study of safety and efficacy of pneumostem® in premature infants with bronchopulmonary dysplasia

Conditions: Bronchopulmonary Dysplasia

Summary: this is a long term follow-up study of the open label, single-center, phase i clinical trial to evaluate the safety of pneumostem® in premature infants with bpd.

bronchopulmonary dysplasia (bpd) is the most common cause of death for premature newborns with low birth weights. in addition, many children who recover from the disease suffer from various complications such as prolonged hospitalization, pulmonary hypertension, and failure to thrive. it has been reported that bone marrow-derived mesenchymal stem cells (bm-msc) can differentiate into pulmonary epithelial and pulmonary endothelial cells. some animal studies showed that bm-mscs differentiate into bronchial cells and type 2 pneumocytes in rats with pneumonia and improve the fibrosis that occur after administration of bleomycin. based on the findings, it is considered that mesenchymal stem cell therapy can help regenerate the damaged lung as well as bpd that cause lung inflammation, fibrosis, deficiency of type 2 pneumocytes, and so on. pneumostem® consists of human umbilical cord blood-derived mesenchymal stem cells and is intended to treat bpd in premature infants. this is a long term follow-up study of the earlier part of the phase i clinical trial.

Eligibility criteria:
inclusion criteria: * all infants who enrolled in the phase 1 pneumostem® clinical trial (nct01297205) exclusion criteria: * infants whose parent or legal guardian did not want to participate in the study

Keywords: human umbilical cord blood-derived mesenchymal stem cells premature infants bronchopulmonary dysplasia lung injury lung diseases hyperplasia ventilator-induced lung injury respiratory lung diseases pathologic processes infant, premature, diseases infant, newborn, diseases
microneedling with regular insulin versus microneedling alone in treatment of atrophic scars

Conditions: Scars; Insulin

Summary: recently, few studies have attempted to test the regenerative effects of human insulin application by microneedling on atrophic scars versus other topical preparations. however, the scars were limited etiologically to acne scars. in addition, a lack of inclusion of a control group instead of comparing topical preparations with insulin was also a limitation to these studies. a control group consisting of microneedling alone would have served as a better comparison in order to determine whether the effects of microneedling are augmented by topical protein-rich preparations.


Eligibility criteria:
inclusion criteria: 1. patients aged 12 to 60 years 2. atrophic scars (traumatic or surgical) 3. completely healed scars exclusion criteria: 1. patients with a tendency or history of hypertrophic or keloidal scars 2. patients who received treatment for their scar in the past 3 months 3. diabetic patients or those with a history of dysglycemia 4. pregnant, or lactating females 5. patients with active infection at the site of scar 6. patients currently receiving isotretinoin treatment or in the past month

Keywords: insulin scars
evaluation of virtual reality to save morphinic in the treatment of vaso-occlusive seizures of sickle cell patients consulting in the emergency room

Conditions: Vaso-occlusive Crisis; Sickle Cell Disease

Summary: the management of pain in the emergency department is a major issue, especially for sickle cell patients who regularly consult for vaso-occlusive seizure (vos). the place of virtual reality remains to be defined in a busy environment, in which the permanence of care generates a significant turn over of medical and paramedical personnel. with its immersive nature, allowing the patient to detach from his immediate environment, wich is often stressful for patients, we can hope that in multimodal management, virtual reality (vr) can contribute to a faster reduction in pain with lower doses of morphine, but so far we have no data. our pilot study aims to assess the effectiveness, feasibility and tolerance of adding virtual reality to the management of vos in sickle cell patients in the er.

it will be a before-after study: this study will be conducted in 2 phases in the emergency department * a period of usual management of sickle cell patients with vos * then a phase during which the device will be used. each phase will last 3 months; the duration of the periods may be shorter if recruitment targets are met. patients will be included consecutively. the main objective of the study is to measure the impact of virtual reality on the total dose of morphine administered to the emergency room in the treatment of vaso-occlusive seizures after initial morphine titration. the primary endpoint is the total dose of morphine (in milligrams), used in the emergency room after initial titration, meaning the dose administered by pca (patient-controlled analgesia) and secondary titrations in the event of a recurrence of painful spikes with analog verbal scale (avs) \>7.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * sickle cell patient consulting in the emergency room for vos * signature free and informed consent exclusion criteria: * consultation in the er for the same reason in the 14 days prior to inclusion (same episode) * emergency room consultation more than 12 times in the previous year * nausea and vomiting at the time of inclusion * history of epilepsy * a visually impaired or hard of hearing patient * pregnant patient * previous inclusion in the study

Keywords: virtual reality vaso occlusive seizure sickle cell disease emergency room pain
cell-free dna in acute stroke

Conditions: Stroke

Summary: cell-free dna (cfdna) is an important pro-inflammatory and prothrombotic mediator. with this study the investigators aim to gain new insights into the role of cfdna in stroke and to perform a combined analysis of cfdna in the hyperacute phase of the disease using blood and thrombus analyses. the main objectives are to analyse cfdna in different stroke etiologies, to investigate the relationship between cfdna and important procedural factors such as secondary embolisation and reperfusion outcomes, to analyse the correlation between blood and thrombus content of cfdna and to investigate the specific source of cfdna in distinct stroke subtypes.


Eligibility criteria:
inclusion criteria: * acute ischemic stroke due to large vessel occlusion (lvo) who require mechanical thrombectomy (detected in ct-scan or mri-scan) * 18 years of age exclusion criteria: * patients currently undergoing immunological therapies. * patients with immunological diseases * patients with systemic infections at the time of admission

Keywords: cell-free dna stroke etiologies reperfusion secondary emboli stroke subtypes
benzonatate dose tolerance study

Conditions: Cough

Summary: this is a single-center, randomized, third party blind, placebo controlled, dose escalation study of benzonatate following single dose administration. the primary oobjective is to assess the safety and tolerability of increasing oral doses of benzonatate following single dose administration in healthy male and female subjects.


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ecg, or clinical laboratory tests. exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results, and in the judgment of the investigator, would make the subject inappropriate for entry into this study.
modeling of regional citrate anticoagulation with a dialysate containing calcium in intermittent hemodialysis (marc)

Conditions: End Stage Renal Disease

Summary: the primary purpose of this study is to validate a mathematical modeling of treatment by intermittent hemodialysis using regional citrate anticoagulation with a dialysate containing calcium

the only visit to the study will be carried out during a usual dialysis session in the intensive care unit of clermont-ferrand university hospital. in addition to the usual care, 2 blood samples will be taken from the blood circuit 1 hour after the start of the hemodialysis session by the nurse in charge of the patient.

Eligibility criteria:
inclusion criteria: * major patient; * man or woman ; * treated with intermittent hemodialysis for chronic renal failure; * in whom intermittent hemodialysis with citrate solution for regional anticoagulation is indicated; * affiliated with a social security scheme; * having given a signed agreement after detailed explanation of the protocol on the basis of the information sheet and likely to comply with it exclusion criteria: * severe hepato-cellular insufficiency (pt \ 1.5 without anticoagulant); * hemoglobin level \<7 g / dl * presenting a psychiatric pathology or cognitive impairment rendering him unable to give informed consent; * persons under guardianship, curatorship, deprived of liberty or safeguard of justice * pregnant or breastfeeding women * patient's refusal to participate in the study.

Keywords: hemodialysis modeling citrate anticoagulation
preoperative prediction of microvascular invasion in hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: microvascular invasion (mvi) has been well demonstrated as an unfavorable prognostic factor for hepatocellular carcinoma (hcc), and patients with mvi have a high risk of tumor recurrence after curative hepatectomy. currently, the diagnosis of mvi is determined on the postoperative histologic examination, which greatly limits its influence on preoperative decision making. therefore, we constructed this prospective study to develop a machine learning-based model for preoperative prediction of mvi by extracting high-dimensional magnetic resonance (mr) image features.

histologically-diagnosed primary hcc after curative hepatectomy. the magnetic resonance image will be imported into the imaging management software (ge healthcare analysis-kit software),and the tumor lesions will manually delineated by two independent radiologists and then reconstruct into three-dimensional images for feature extraction. the radiomic textural features including grayscale histogram, transform matrix, wavelet transform and filter transformation are automatically extracted by the analysis-kit software.the high-throughput extracted features will be then selected by the univariate analysis, and a prediction model will be developed based on machine learning algorithm in a training set in which patients were collected from a retrospective study. and in the present study, an independent validation set will be collected and used to validate the prediction accuracy of the model.

Eligibility criteria:
inclusion criteria: * asian patients aged 18～80 years old; * hcc without macroscopic vascular invasion according to imaging findings; * child pugh a-b stage; * receipt of preoperative gd-eob-dtpa enhanced mr imaging of the abdomen within one month before surgery; * histologically-diagnosed primary hcc after curative hepatectomy; exclusion criteria: * combined hepatocellular-cholangiocarcinoma; * with extra-hepatic metastasis or macrovascular invasion; * with incomplete clinical and imaging data; * non-radical resection;

Keywords: magnetic resonance image features pathological differentiation machine learning-based model
exercise habits: a survey of individuals with parkinson's disease living in the community

Conditions: Parkinson Disease

Summary: this study aims to evaluate the exercise regimens of individuals with parkinson's.


Eligibility criteria:
inclusion criteria: * diagnosed with parkinson's disease * able to speak english exclusion criteria: * no internet access

Keywords: exercise survey
trial of two adagrasib dosing regimens in nsclc with kras g12c mutation (krystal 21)

Conditions: Advanced Cancer; Metastatic Cancer; Malignant Neoplasm of Lung

Summary: this study will evaluate the efficacy of two dosing regimens of adagrasib (600 mg bid versus 400 mg bid) in patients with nsclc with kras g12c mutation.

ca239-0012 is a phase 2 study of adagrasib monotherapy in which patients are randomized between two dosing regimens. the study will evaluate the efficacy of two dosing regimens of adagrasib (600 mg bid without regard to food versus 400 mg bid with food) in patients with nsclc with kras g12c mutation and who have received prior treatment with a platinum-based regimen and immune checkpoint inhibitor therapy.

Eligibility criteria:
key inclusion criteria: * are at least 18 years old (or old enough to legally make their own treatment decisions, according to local laws). * have advanced nsclc or metastatic nsclc (nsclc that started in the lungs and then spread to other parts of the body) with the kras g12c mutation. * have had previous treatment with 1) chemotherapy that included a drug called cisplatin or a drug called carboplatin and 2) a type of drug called an immune checkpoint inhibitor. * have recovered from their prior treatment and blood tests are within a safe range. key exclusion criteria: * have had previous treatment with a drug that targets kras g12c. * have cancer that can potentially be removed with surgery. * patients with brain lesions are not eligible if 1) any untreated brain lesions are \> 2.0 cm in size 2) any brainstem lesions are present 3) ongoing steroid dosing \>10 mg daily prednisone (or equivalent) and 4) poorly controlled (\> 1/week) generalized or complex partial seizures or neurologic progression/instability due to brain lesions. * have certain medical conditions or need to take certain medications that, in the opinion of a trial doctor, could make it unsafe for them to participate or difficult to complete the trial assessments, or are pregnant.

Keywords: kras g12c non-small cell lung cancer metastatic cancer nsclc
special drug use investigation of ciproxan injection in pediatrics

Conditions: Cystitis / Pyelonephritis / Cystic Fibrosis / Anthrax

Summary: the objective in this study is collecting post-marketing information on the safety and efficacy of ciproxan injection under the routine clinical practice.

this company-sponsored study is an one-arm, prospective, and, cohort-observational study in pediatrics (less than 15 years old) administered ciproxan injection. all patients in the contracted institute should be enrolled into this study. consequently 45 cases will be is planned to be enrolled in three-year period target population is pediatrics with a diagnosis of complicated cystitis, pyelonephritis, cystic fibrosis, or anthrax infected by ciprofloxacin-active microorganisms, i.e. bacillus anthracis, escherichia coli, pseudomonas aeruginosa. the treatment should be performed based on the product label in japan. the standard observation will be performed until the last date of the treatment.

Eligibility criteria:
inclusion criteria: * female and male pediatric patients (less than 15 years old) with a diagnosis of complicated cystitis, pyelonephritis, cystic fibrosis, or anthrax infected by ciprofloxacin-active microorganisms, i.e. bacillus anthracis, escherichia coli, pseudomonas aeruginosa. * patients for whom the decision to initiate treatment with ciproxan injection was made as per investigator's routine treatment practice. exclusion criteria: * n/a

Keywords: ciprofloxacin japan post-marketing surveillance
a phase 1, open-label study evaluating the pharmacokinetics and drug-drug interaction of vx-993 in healthy adults

Conditions: Pain

Summary: the purpose of this study is to evaluate the pharmacokinetics (pk), drug-drug interaction, and safety and tolerability of vx-993 in healthy participants.

this clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (that is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(a) of the public health service act and 42 cfr 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the public health service act or 42 cfr 11.24 and 11.44.).

Eligibility criteria:
key inclusion criteria: * body mass index (bmi) of 18.0 to 32.0 kilogram per meter square (kg/m\^2) * a total body weight of more than (\>) 50 kg * nonsmoker or ex-smoker for at least 3 months before the first study drug dose key exclusion criteria: * history of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug. * any condition possibly affecting drug absorption, distribution, metabolism, or excretion other protocol defined inclusion/exclusion criteria may apply.
the role of high resolution-computed tomography (ct) in tuberculosis (tb) outbreak investigation

Conditions: Tuberculosis

Summary: the aim of this study is to evaluate the role of high-resolution computed tomography of the chest (hrct) in the investigation of an outbreak of tb that developed in the south korean army.

outbreak investigation including tuberculin skin test (tst), quantiferon® tb gold in-tube (qft), and simple chest radiography (cxr) will be performed. for participants with any abnormal findings in these tests, hrct will be carried out. active pulmonary tb is diagnosed based on sputum studies or hrct findings. in addition, participants with positive results both in tst and qtf will be treated as having a latent tb infection (ltbi). tst and qtf were repeated in participants with positive result in one of these tests. cxr will be repeated in all participants at 3 and 6 months of follow-up.

Eligibility criteria:
inclusion criteria: * all soldiers who assigned to the military battery where a tuberculosis outbreak occurred exclusion criteria: * soldiers who could not complete study

Keywords: tuberculosis outbreaks
irape, irisin and il-34 in patients with type 2 diabetes

Conditions: Type2 Diabetes Mellitus

Summary: aim: this study aimed to evaluate the role of extracellular part of insulin regulated aminopeptidase (irape), il-34, irisin, and visfatin in the development of insulin resistance in patients with type 2 diabetes mellitus. methods: parallel study enrolled 60 non-diabetic control subjects and 60 newly-diagnosed type 2 diabetics, matched for age, body mass index and sex ratio.

aim: this study aimed to evaluate the role of extracellular part of insulin regulated aminopeptidase (irape), il-34, irisin, and visfatin in the development of insulin resistance in patients with type 2 diabetes mellitus. methods: parallel study enrolled 60 non-diabetic control subjects and 60 newly-diagnosed type 2 diabetics, matched for age, body mass index and sex ratio. anthropometric parameters, blood glucose, fasting plasma insulin, insulin resistance index (homa-ir), il34, irisin, irape, visfatin and glycated hemoglobin were assessed. conclusion: il-34 and visfatin levels were significantly increased, while both irisin and irape levels were significantly decreased in patients with type 2 diabetes. theses aforementioned parameters were significantly correlated with insulin resistance. these findings indicate that, il-34, irisin and irape may play a vital role in t2dm and in diabetes associated insulin resistance. additionally, the investigator's findings proposed that, irape may be a useful and direct marker for detection of insulin resistance state.

Eligibility criteria:
inclusion criteria: * newly diagnosed type 2 diabetes and non-diabetic control subjects from 35 to 65 years old were enrolled in this study. exclusion criteria: * individuals with inflammatory diseases, cushing's syndrome, thyroid disorders, infectious diseases, cancers, hepatic diseases and renal impairment. subjects on insulin or other medications that could affect glucose metabolism or pro-inflammatory cytokines assessment (glucocorticoids, beta-adrenergic agonists, thiazides, etc.....) were also excluded from study

Keywords: type 2 diabetes mellitus il-34 irisin irape visfatin insulin resistance homa-ir
results of the tactys implant in proximal interphalangeal joint arthroplasty

Conditions: Interphalangeal; Osteoarthritis, Proximal (Bouchard)

Summary: study at middle term of the functional and radiographic results of proximal interphalangeal joint arthroplasty with the tactys prothesis. the aim is to evaluate if the short term results are maintained in time.

the inclusion criteria is any patient who has undergone a proximal interphalangeal joint arthroplasty with the tactys prothesis between january 2015 to january 2020 in the centre chirurgical emile gallé in nancy. the functional results evaluated are range of motion, force, pain, functional score as quick dash and the radiological one are clinodactyly, periprosthetic ossifications and loosening, dislocation and implant subsidence. data is registered from the medical folder of every patient.

Eligibility criteria:
inclusion criteria: * one or more proximal interphalangeal joint arthroplasty of long fingers with the tactys prosthesis * between january 2015 to january 2020 * major * centre chirurgical emile gallé, centre hospitalier régional universitaire de nancy exclusion criteria: * minor

Keywords: tactys prosthesis